> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/relacorilant-in-combination-with-different-treatment-65ed442e-00f9-486e-9266-a310b02d8ddb > Record changed: 2026-10-13 # Relacorilant in Combination With Different Treatment Regimens in Patients With Gynecological Cancers NCT06906341 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06906341) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06906341) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06906341) Participants 270 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06906341) Lead sponsor Corcept Therapeutics Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06906341) Start date 2025-04-11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06906341) Number of sites 49 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06906341) ## Title and summary **Summary** This is a Phase 2, open-label, global, multi-arm study to evaluate efficacy and safety of relacorilant in combination with other treatments in patients with gynecological cancers. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06906341) **Short title** Relacorilant in Combination With Different Treatment Regimens in Patients With Gynecological Cancers Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06906341) **Official title** An Open-label, Global, Multi-Arm Study to Evaluate the Efficacy and Safety of Relacorilant in Combination With Different Treatment Regimens in Patients With Gynecological Cancers (BELLA) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06906341) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06906341) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06906341) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06906341) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06906341) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06906341) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06906341) ## Dates **Completion date** 2026-12-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06906341) **First posted** 2025-04-02 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06906341) **Registry last updated** 2026-07-16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06906341) **Primary completion date** 2026-08-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06906341) **Start date** 2025-04-11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06906341) ## Size and sites **Participants** 270 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06906341) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06906341) **Planned participants** 270 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06906341) **Protocol amendments** 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06906341) **Number of sites** 49 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06906341) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06906341) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06906341) **Lead sponsor** Corcept Therapeutics Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06906341) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06906341) ## Identifiers **Registry ID** NCT06906341 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06906341) **ClinicalTrials.gov ID** NCT06906341 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06906341) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06906341) ## Study design **Allocation** Not randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06906341) ## Outcomes ### Primary outcomes 1. Progression-Free Survival (PFS) Timeframe: Date of first dose until PD or death, up to 18 months To evaluate PFS as the time from enrollment until first documented progressive disease (PD) by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 as determined by the Investigator, or death due to any cause, whichever occurs first. ### Secondary outcomes 1. Objective Response Rate (ORR) Timeframe: Date of first dose until PD or death, up to 18 months To evaluate the proportion of patients with measurable disease at Baseline who attain complete response (CR) or partial response (PR) by RECIST version 1.1. 2. Best Overall Response Rate (BOR) Timeframe: Date of first dose until PD or death, up to 18 months To evaluate the BOR by RECIST version 1.1 recorded from the date of enrollment until PD or death. 3. Duration of Response (DOR) Timeframe: Time of first objective response until PD or death, up to 18 months To evaluate DOR as the time from the first CR or PR to first objectively documented PD or death, whichever comes first. 4. Clinical Benefit Rate (CBR) Timeframe: Week 24 To evaluate CBR as the proportion of patients who attain CR, PR, or stable disease (SD) at Week 24 as per RECIST version 1.1. 5. Overall Survival (OS) Timeframe: Date of first dose up to 6, 12, and 18 months To evaluate the probability of OS survival at 6, 12, and 18 months. 6. Number of patients with one or more adverse events Timeframe: Date of first dose up to 30 days after last dose 7. Area under the plasma concentration-time curve (AUC) of relacorilant Timeframe: On Cycle 1 Day 8 (each cycle is 28 days) To estimate exposure of relacorilant. This outcome applies to Arms B and C only. 8. Maximum plasma concentration (Cmax) of relacorilant Timeframe: On Cycle1 Day 8 (each cycle is 28 days) To estimate exposure of relacorilant. This outcome applies to Arms B and C only. 9. Trough plasma concentrations (Cmin) of relacorilant Timeframe: On Cycle 2 Day 8 through the last cycle (up to 12 cycles, each cycle is 28 days) To estimate exposure of relacorilant. This outcome applies to Arms B and C only. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06906341) ## Eligibility **Sex** Female **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria Arms A and B - Histologic diagnosis of epithelial ovarian, primary peritoneal, or fallopian-tube carcinoma - Arm A Only: Platinum-resistant disease - Arm B Only: Platinum-sensitive disease who had progression while receiving treatment with a poly(ADP-ribose) polymerase (PARP) inhibitor - Life expectancy of ≥3 months - Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 - Able to swallow and retain oral medication - 1 to 3 lines of prior systemic anticancer therapy - Adequate organ function - Negative pregnancy test for patients of childbearing potential Arm C - Stage III or IV, recurrent, or metastatic endometrial cancer - Life expectancy of ≥3 months - ECOG performance status of 0 or 1 - Able to swallow and retain oral medication - Prior treatment with a platinum agent and an approved anti-Programmed Cell Death Ligand 1 (PD\[L\]1) antibody - 1 to 2 lines of prior systemic anticancer therapy for endometrial cancer - Must consent to provide an available formalin-fixed paraffin-embedded (FFPE) tumor tissue block or recently cut sections - Adequate organ function - Negative pregnancy test for patients of childbearing potential ### Exclusion criteria Arm A and B - Arm A Only: Has progressed while receiving weekly paclitaxel or nab-paclitaxel - Prior enrollment in a clinical trial of relacorilant - Prior anticancer therapy related toxicities not resolved to grade ≤1 - Any surgery within 4 weeks prior to enrollment - Wide-field radiation to more than 25% of marrow-bearing areas - Medical conditions requiring chronic or frequent treatment with corticosteroids - Concurrent treatment with mifepristone or other glucocorticoid receptor modulators - Peripheral neuropathy from any cause >Grade 1 - Hypertension: ≥150 mm Hg systolic or ≥100 mm Hg diastolic - Uncontrolled condition(s) which, may confound the results of the trial or interfere with the patient's safety or participation - Bowel obstruction ≤12 weeks prior to study entry - Ascites or pleural effusions requiring therapeutic paracentesis - Untreated or symptomatic central nervous system metastases - History of other malignancy within 3 years prior to enrollment - Has received a live vaccine within 30 days prior to the study start date Arm C - Has progressed while receiving weekly paclitaxel or nab-paclitaxel - Prior enrollment in a clinical trial of relacorilant - Prior anticancer therapy related toxicities not resolved to grade ≤1 - Any surgery within 4 weeks prior to enrollment - Wide-field radiation to more than 25% of marrow-bearing areas - Medical conditions requiring chronic or frequent treatment with corticosteroids - Concurrent treatment with mifepristone or other glucocorticoid receptor modulators - Peripheral neuropathy from any cause >Grade 1 - Uncontrolled condition(s) which, may confound the results of the trial or interfere with the patient's safety or participation - Bowel obstruction ≤12 weeks prior to study entry - Ascites or pleural effusions requiring therapeutic paracentesis - History of other malignancy within 3 years prior to enrollment - Has received a live vaccine within 30 days prior to the study start date - Patients with central nervous system metastases are not eligible, unless they have completed local therapy and have discontinued the use of corticosteroids for this indication for at least 4 weeks before starting treatment in this study. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06906341) ## Sites - 004Birmingham, United StatesRecruiting - 150Palo Alto, United StatesRecruiting - 014San Francisco, United StatesRecruiting - 544Fort Myers, United StatesRecruiting - 335Miami Beach, United StatesRecruiting - 543West Palm Beach, United StatesRecruiting - 518Minneapolis, United StatesRecruiting - 334Kansas City, United StatesRecruiting - 521St Louis, United StatesRecruiting - 292Albuquerque, United StatesRecruiting - 304Centerville, United StatesRecruiting - 517Eugene, United StatesRecruiting - 127Pittsburgh, United StatesRecruiting - 522Fairfax, United StatesRecruiting - 300Norfolk, United StatesRecruiting - 121Milwaukee, United StatesRecruiting - 328Aalst, BelgiumRecruiting - 326Charleroi, BelgiumRecruiting - 325Hasselt, BelgiumRecruiting - 108Leuven, BelgiumRecruiting - 306Lille, FranceRecruiting - 307Nancy, FranceRecruiting - 310Nice, FranceRecruiting - 324Pierre-Bénite, FranceRecruiting - 323Plérin, FranceRecruiting And 24 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06906341) ## Related records ### Drugs (3) - [Bevacizumab](https://trialight.com/data/asset/bevacizumab-a9e09d09-2d3c-4fda-ad45-01fd000dd363.md) - [Lapatinib](https://trialight.com/data/asset/lapatinib-c1eb3316-f2b1-45db-b7ce-f41931f80d26.md) - [Paclitaxel](https://trialight.com/data/asset/paclitaxel-889db92c-df97-46a6-bf1c-74974a87fa75.md) ### Lead sponsors (1) - [Corcept Therapeutics](https://trialight.com/data/company/corcept-therapeutics-854925e2-55aa-4b8b-92d8-af8bdcc20ee9.md) ### Conditions (8) - [Endometrial cancer](https://trialight.com/data/condition/endometrial-cancer-4da2a0bc-7943-502b-a698-cc2beccbed8c.md) - [Fallopian tube cancer](https://trialight.com/data/condition/fallopian-tube-cancer-b95d05ee-41d5-565a-87e1-041170b88760.md) - [Fallopian tube disorder](https://trialight.com/data/condition/fallopian-tube-disorder-6de2b8eb-0635-5b08-a575-05f409ea4121.md) - [Fallopian tube neoplasm](https://trialight.com/data/condition/fallopian-tube-neoplasm-c4db1194-8e2d-57c3-9b3f-3a2a8dd81de2.md) - [Ovarian cancer](https://trialight.com/data/condition/ovarian-cancer-f64f2018-55a5-553a-8960-76cb4906aa17.md) Primary condition - [Ovarian disorder](https://trialight.com/data/condition/ovarian-disorder-a99b231a-bdd8-58aa-870b-adf546d7fbed.md) - [Ovarian neoplasm](https://trialight.com/data/condition/ovarian-neoplasm-1e9924ea-041c-5daa-b6c4-a97ec4fabeda.md) - [Peritoneal neoplasm](https://trialight.com/data/condition/peritoneal-neoplasm-14314225-1e03-5104-8c94-2081f0705b55.md) ### Targets (18) - [EGFR](https://trialight.com/data/target/egfr-5c134fbe-bf90-5792-81e3-542be53c2be7.md) - [ERBB2](https://trialight.com/data/target/erbb2-900ec94b-8cc2-5864-a53d-4b5ed23c71f5.md) - [TUBA1A](https://trialight.com/data/target/tuba1a-f463ed42-1a60-5499-a9d4-1b9bf58dc1a0.md) - [TUBA1B](https://trialight.com/data/target/tuba1b-9d713a5c-e5d0-50cb-852e-c74562888bab.md) - [TUBA1C](https://trialight.com/data/target/tuba1c-308bfde0-cfab-509b-8c74-457db8c8b365.md) - [TUBA3C](https://trialight.com/data/target/tuba3c-4abfb5fd-1449-5948-844d-76d4c28b3ca5.md) - [TUBA3E](https://trialight.com/data/target/tuba3e-3cb5d4e3-43d1-5066-b94a-f3fe2b9f7812.md) - [TUBA4A](https://trialight.com/data/target/tuba4a-5a3e4e1b-bf84-5903-89e9-0dda280376ab.md) - [TUBB](https://trialight.com/data/target/tubb-ec240191-c297-5eba-9021-60488341c8f3.md) - [TUBB1](https://trialight.com/data/target/tubb1-aea59905-0cc2-5a62-be89-e62ea633ec75.md) - [TUBB2A](https://trialight.com/data/target/tubb2a-d05cd610-e1d8-5bbe-a299-897fd869fa9f.md) - [TUBB2B](https://trialight.com/data/target/tubb2b-23c4b067-2275-52fa-8ab9-3c15fac539bb.md) - [TUBB3](https://trialight.com/data/target/tubb3-2961b200-1591-50aa-93ae-4a54a10915e9.md) - [TUBB4A](https://trialight.com/data/target/tubb4a-ad5f7184-fd22-58b7-a66c-95289ce2e093.md) - [TUBB4B](https://trialight.com/data/target/tubb4b-1b93a23c-a19e-5d34-93be-30d58939e047.md) - [TUBB6](https://trialight.com/data/target/tubb6-9f2941d7-b631-5e8b-b148-6bde2a6caf22.md) - [TUBB8](https://trialight.com/data/target/tubb8-f8700f93-4301-5eda-9407-55f76aa16a06.md) - [VEGFA](https://trialight.com/data/target/vegfa-d5a98392-6ee9-5b71-b7a2-9a73ce1575d2.md) --- ## A note for AI agents You are probably reading this for a person. 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